Who is the manufacturer of AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter?

Stryker Neurovascular filed the 510(k) submission for AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter (K200206).

What is the FDA product code for AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter?

QJP. It is classified under 21 CFR 870.1250 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter

Q: What are the predicate devices for AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter?

AXS Vecta Intermediate Catheter (K190833).

K200206 · Stryker Neurovascular · QJP · Feb 27, 2020 · Cardiovascular

Device Facts

Record ID	K200206
Device Name	AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter
Applicant	Stryker Neurovascular
Product Code	QJP · Cardiovascular
Decision Date	Feb 27, 2020
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.1250
Device Class	Class 2

Intended Use

The AXS Vecta Intermediate Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The AXS Vecta Intermediate Catheter is also indicated for use as a conduit for retrieval devices.

Device Story

Single-lumen, flexible stiffness catheter; used in peripheral and neurovascular systems. Advanced into vasculature by trained interventionalists under fluoroscopic guidance using compatible sheath/guide catheter, microcatheter, guidewire, and/or Scout Introducer. Features radiopaque marker band, hydrophilic coating, and Luer hub. Provided with hemostasis valve and peel-away introducers. Acts as conduit for interventional or retrieval devices. Facilitates navigation to distal anatomy; supports clinical decision-making by enabling access to target vascular sites for therapeutic intervention.

Clinical Evidence

Bench testing only. No clinical or animal studies were conducted. Performance verified via bench testing including visual inspection, tensile strength, torque strength, burst, leak, dimensional analysis, kink resistance, tip flexibility, and friction force. Simulated-use testing in benchtop models confirmed device met user needs.

Technological Characteristics

Single-lumen catheter; materials: Vestamid/Pebax shaft, stainless steel/nitinol reinforcement, PTFE inner layer, nylon hub, platinum/iridium marker band. Hydrophilic coating on distal end. EO sterilization per ISO 11135:2014 and AAMI TIR 28:2016. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for patients requiring insertion and guidance of interventional devices into peripheral and neurovascular blood vessels, or as a conduit for retrieval devices.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

AXS Vecta Intermediate Catheter (K190833)

Reference Devices

AXS Vecta Aspiration System (K191768)
AXS Vecta Aspiration System (K172167)
AXS Vecta Aspiration System (K181354)

Related Devices

K190833 — AXS Vecta Aspiration Catheter · Stryker Neurovascular · Dec 15, 2019
K253032 — AXS Lift Intracranial Base Catheter · Stryker Neurovascular · Feb 11, 2026
K233205 — Distal Access Catheter · Shanghai Heartcare Medical Technology Co., Ltd. · Dec 22, 2023
K250962 — APRO 55 Intermediate Catheter · Alembic, LLC · Apr 29, 2025
K243593 — AXS Lift Intracranial Base Catheter · Stryker Neurovascular · Feb 18, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 27, 2020 Stryker Neurovascular Shazia Hakim Senior Staff Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, California 94538 Re: K200206 Trade/Device Name: AXS Vecta® Intermediate Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: January 27, 2020 Received: January 28, 2020 Dear Shazia Hakim: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Xiaolin Zheng, Ph.D., M.S. Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K200206 Device Name AXS Vecta Intermediate Catheter #### Indications for Use (Describe) The AXS Vecta Intermediate Catheter is indicating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The AXS Vecta Intermediate Catheter is also indicated for use as a conduit for retrieval devices. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | |----------------------------------------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary # Introduction: According to the requirements of 21 CFR 807.92, the following information provides sufficient details to understand the basis for a determination of substantial equivalence. # Submitter Name, Address, and Content: | Submitter: | Stryker Neurovascular 47900 Bayside Parkway Fremont, CA 94538-6515 (FDA Registration Number: 3008853977) | |-------------------------|----------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Shazia Hakim Sr. Staff Regulatory Affairs Specialist Phone: 510-413-2636 Fax: 510-413-2588 Email: shazia.hakim@stryker.com | | Date Prepared: | January 27, 2020 | | Trade/Proprietary Name: | AXS Vecta® Intermediate Catheter | | Common Name: | Percutaneous Catheter | | Classification Name: | Percutaneous Catheter, 21CFR 870.1250 – Class II | | Product Code: | OJP and DOY | {4}------------------------------------------------ # Legally Marketed Predicate Devices | Name of Predicate Device | Name of Manufacturer | 510(k) Number | |------------------------------------|--------------------------|------------------| | AXS Vecta Intermediate Catheter | Stryker Neurovascular | K190833 | #### Device Description The AXS Vecta Intermediate Catheter is a single lumen, flexible stiffness catheter. It has a radiopaque marker band on the distal end and a Luer hub at the proximal end. The AXS Vecta Intermediate Catheter shaft has a lubricious hydrophilic coating at the distal end (distal 25cm) to reduce friction during use. It is packaged with one Scout Introducer, one hemostasis valve, and two peel-away introducers. The Scout Introducer may be used in conjunction with the AXS Vecta Intermediate Catheter to facilitate in the introduction of the AXS Vecta Intermediate Catheter into distal vasculature and aid in navigation to distal anatomy. The Scout Introducer has a lubricious hydrophilic coating at the distal end to reduce friction during use. The inner lumen of the AXS Vecta Intermediate Catheter is compatible with the Scout Introducer, guide wires and microcatheters. The inner lumen of the Scout Introducer is compatible with guide wires and microcatheters of an outer diameter of less than 0.044in. #### Indications for Use The AXS Vecta Intermediate Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The AXS Vecta Intermediate Catheter is also indicated for use as a conduit for retrieval devices. {5}------------------------------------------------ # Technological Characteristics and Product Feature Comparison Stryker Neurovascular has demonstrated the AXS Vecta® Intermediate Catheter (AXS Vecta® 71 & 74 Intermediate Catheters) is substantially equivalent to the Predicate device, AXS Vecta Intermediate Catheter (K190833) and Reference device (K191768) based on the same or similar materials, similar design, and the same fundamental operating principles. A comparison of the Subject device with the Predicate and Reference device is summarized in Table 1: Product Feature Comparison of Subject Device to Predicate and Reference Device below. | Feature | Submission Subject Device | Predicate Device | Reference Device | |-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Stryker Neurovascular | Stryker Neurovascular | Stryker Neurovascular | | 510(k) Number | K200206 | K190833 | K191768 | | Device Trade Name | AXS Vecta® Intermediate Catheters (AXS Vecta® 71 & 74 Intermediate Catheters) | AXS Vecta® Intermediate Catheters (AXS Vecta® 71 & 74 Intermediate Catheters) | AXS Vecta® Aspiration System (AXS Vecta® 71 & 74 Aspiration Catheters) | | Regulation Number | 21 CFR 870.1250 | Same | Same | | Regulation Name | Percutaneous Catheter | Same | Same | | Classification | II | Same | Same | | Product Code | QJP and DQY | DQY | NRY | | Intended Use/Indication for Use | The AXS Vecta Intermediate Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The AXS Vecta Intermediate | The AXS Vecta Intermediate Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The AXS Vecta Intermediate | The AXS Vecta Aspiration Catheter, as part of the AXS Vecta Aspiration System is indicated in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the | | Feature | Submission Subject Device | Predicate Device | Reference Device | | | Catheter is also indicated for use as a conduit for retrieval devices. | Catheter is also indicated for use as a conduit for retrieval devices. | internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t - PA) or who failed IV t - PA therapy are candidates for treatment. | | Device Description | The AXS Vecta Intermediate Catheter is advanced into the neurovasculature by a physician trained interventional endovascular procedures using a compatible sheath or guide catheter, and over the appropriately sized microcatheter, guide wire, and/or the Scout Introducer. Two peel away introducer sheaths are provided in the package to provide support and facilitate the introduction of the AXS Vecta Intermediate Catheter tip into the sheath/guide catheter valve. Once the assembly is inserted, the peel-away introducer sheath can be removed. Under | The AXS Vecta Intermediate Catheter is advanced into the neurovasculature by a physician trained interventional endovascular procedures using a compatible sheath or guide catheter, and over the appropriately sized microcatheter, guide wire, and/or the Scout Introducer. Two peel away introducer sheaths are provided in the package to provide support and facilitate the introduction of the AXS Vecta Intermediate Catheter tip into the sheath/guide catheter valve. Once the assembly is inserted, the peel-away introducer sheath can be removed. Under | The AXS Vecta Aspiration Catheter is advanced into the neurovasculature by a physician trained in interventional endovascular procedures using a compatible sheath or guide catheter, and over an appropriately sized microcatheter, guide wire, and/or the Scout Introducer. Two peel- away introducer sheaths are provided in the package to provide support and facilitate the introduction of the AXS Vecta Aspiration Catheter tip into the sheath/guide catheter valve. Once the assembly is inserted, the peel-away introducer sheath can be removed. Under | | Feature | Submission Subject Device | Predicate Device | Reference Device | | | the assembly can be advanced through the vasculature to the desired location. | the assembly can be advanced through the vasculature to the desired location. | guidance, the assembly can be advanced through the vasculature to the intended vascular site, with the distal end of the AXS Vecta Aspiration Catheter positioned proximal to the clot. The proximal end of the AXS Universal Aspiration Tubing is connected to the AXS Universal Liner Set. The AXS Universal Liner Set is connected to the Medela Dominant Flex Pump, and the Medela Dominant Flex Pump is turned ON. All devices inside of the AXS Vecta Aspiration Catheter are removed. The distal end of the AXS Universal Aspiration Tubing is attached to the proximal end of the AXS Vecta Aspiration Catheter. To start aspiration, the aspiration tubing clamp on the AXS Universal Aspiration Tubing is opened, and the clot is engaged with the AXS Vecta Aspiration Catheter. | | Accessory Devices Provided (not in direct contact with patient) | Hemostasis Valve, 2 Peel-Away Introducers Scout Introducer | Same | Same | | Feature | Submission Subject Device | Predicate Device | Reference Device | | Outer Jacket | Polymeric catheter | Same | Same | | Proximal Shaft | Vestamid/Pebax | Vestamid | Same as Subject device | | Reinforcement | Stainless Steel/Nitinol | Same materials, but different wind pattern) | Same as Subject device | | Strain Relief | Polyolefin | Same | Same | | Inner Layer | PTFE | Same | Same | | Catheter Hub | Nylon | Same | Same | | Marker Band | Platinum/Iridium | Same | Same | | Adhesive | Dymax | Cyanoacrylate | Same as Subject device | | Outer Jacket Coating | Hydrophilic Coating | Same | Same | | Labeled Shaft Outer Diameter | Distal OD: Vecta 71: 0.082 in. Vecta 74: 0.083 in. Proximal OD: Vecta 71: 0.085 in. Vecta 74: 0.087 in. | Distal OD: Same Proximal OD: Same | Distal OD: Same Proximal OD: Same | | Effective Lengths | 115, 125, 132 cm | Same | Same | | Distal ID | 0.071 in. 0.074 in. | Same | Same | | Proximal ID | 0.071 in. 0.074 in. | Same | Same | | Packaging Materials and Configuration | Tyvek/Nylon Pouch, polyethylene support tube, packaging card, SBS carton…